1 Reporting Quality in Acupuncture Trials: An Assessment of the Literature to Update the NIH Consensus Conference Symposium for Portland Area Research in CAM (SPARC) April 16, 2011 Ryan J Milley, MAcOM, LAc Research Associate

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3 Conclusions from NIH Consensus Development Conference  “…promising results have emerged … showing efficacy of acupuncture in adult postoperative and chemotherapy related nausea and vomiting and in postoperative dental pain…”  “...acupuncture may be useful as an adjunct treatment, or an acceptable alternative…in addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma...” 3

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66 This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information...we recommend consulting the National Institutes of Health's MedlinePlus.

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8  Continues to be cited as a definitive source for conditions in which acupuncture is effective  Outdated statement 600+ RCTs have been conducted since RCTs have been conducted since 1997  Numerous RCTs on previously unstudied conditions have been conducted 8 Conclusions from NIH Consensus Development Conference

9 Aim: Update the NIH recommendations  Develop an objective & comprehensive quality of reporting instrument Systematic reviews and meta-analyses use a heterogenous group of subjective instruments Systematic reviews and meta-analyses use a heterogenous group of subjective instruments  Couple quality score findings with primary study outcome(s)  Consider the value of differing research trial designs, e.g. sham or usual care controls 9

10 Methods  Developed the Oregon CONSORT STRICTA Instrument (OCSI) CONSORT: Consolidated Standards of Reporting Trials [22 item guideline] CONSORT: Consolidated Standards of Reporting Trials [22 item guideline] Published 1996, updated 2001 & 2010Published 1996, updated 2001 & 2010 STRICTA: Standards for Reporting Interventions in Controlled Trials of Acupuncture [6 item guideline] STRICTA: Standards for Reporting Interventions in Controlled Trials of Acupuncture [6 item guideline] Modifies CONSORT to reflect acupuncture interventions; published 2001, updated 2010Modifies CONSORT to reflect acupuncture interventions; published 2001, updated

11 Methods: OCSI Development  Adapts CONSORT and STRICTA guidelines to a 27 question instrument  Comprehensive in nature Most items contain sub-questions - 63 total Most items contain sub-questions - 63 total Items range from aspects pertaining to Items range from aspects pertaining to Bias (randomization)Bias (randomization) Treatment relevance (Practitioner experience with the condition)Treatment relevance (Practitioner experience with the condition) External validity (generalizabilty of findings)External validity (generalizabilty of findings) 11

12 OCSI Development & Findings  Scores questions as Yes=2, Partial=1, No=0, or N/A 333 RCTs met the inclusion criteria 333 RCTs met the inclusion criteria From 27 countries and 141 journals From 27 countries and 141 journals 12

13 OCSI Development & Findings  Scores questions as Yes=2, Partial=1, No=0, or N/A 333 RCTs met the inclusion criteria 333 RCTs met the inclusion criteria From 27 countries and 141 journals From 27 countries and 141 journals Evid Based Complement Alternat Med doi: /2011/

% (P<0.001)

% (P<0.001) Mean OCSI Score 63% SD 16.5

16 Methods  Assessed quality of reporting in the 333 acupuncture RCTs published in English from  Inclusion criteria: Treatment with acupuncture needles using manual and/or electro-stimulation Treatment with acupuncture needles using manual and/or electro-stimulation Control groups of no treatment, a sham procedure, or usual biomedical care Control groups of no treatment, a sham procedure, or usual biomedical care Clinical end points; not experimental Clinical end points; not experimental 16

17 Methods  Quality threshold set at 70% OCSI score  Indexed variables of each RCT related to treatment methodologies and outcomes  RCTs categorized as: Efficacy Trials Efficacy Trials Comparative Effectiveness Research (CER) Trials Comparative Effectiveness Research (CER) Trials 17

18 Differing Lenses 18 Efficacy Sham acupuncture control. Better than placebo? CER Usual care control. At least as good as usual care?

19 Results  133 (40%) RCTs scored ≥70% on OCSI  Represent 43 varied conditions  Published in 76 differing journals  Conducted in 21 countries Germany & USA - 31 RCTs each Germany & USA - 31 RCTs each UK - 16 RCTs UK - 16 RCTs Sweden - 12 RCTs Sweden - 12 RCTs Norway - 7 RCTs Norway - 7 RCTs 19

20 Results 20 NIH Consensus Development Conference Category Distribution of RCTs (n) NIH “Showing efficacy” list 5% (7) NIH “May be useful” list 50% (66) NIH “Potential Future Research” list 45% (60)

21  Efficacy Trial Designs, i.e. sham acupuncture control 58% (70/133) 58% (70/133)  Comparative Effectiveness Research Trial Designs, i.e. Usual care control 32% (42/133) 32% (42/133)  Combined Efficacy & CER Trial Designs 10% (12/133) 10% (12/133) 21 Results

22 Results  Top 5 most investigated areas Pregnancy & labor related conditions (n=18) Pregnancy & labor related conditions (n=18) Chronic low back pain (n=13) Chronic low back pain (n=13) Headache conditions(n= 11) Headache conditions(n= 11) Osteoarthritic conditions (n=10) Osteoarthritic conditions (n=10) Neck & shoulder pain conditions (n=10) Neck & shoulder pain conditions (n=10) 22

23 Top 5 Investigated Conditions 23 Pregnancy & Labor Related ConditionTrials (n)Outcome Pain During Labor44+ Emesis in Pregnancy32+; 1- Initiation of Labor32+; 1- Pain During IVF Procedures33+ Pregnancy Rate with IVF Procedures32+; 1- Breech Presentation11+ Pelvic Pain During Pregnancy11+ TOTAL1815+; 3- Primary outcome assessed as: Positive: + or Negative: -

2424 Top 5 Investigated Conditions ConditionTrials (n)Outcome Chronic Low Back Pain1311+; 2- Headache (Migraine & TTH)114+; 7- Osteoarthritis (Knee)108+; 2- Neck & Shoulder Pain108+; 2- Primary outcome assessed as: Positive: + or Negative: -

2525 Top 5 Investigated Conditions ConditionTrials (n)Outcome Chronic Low Back Pain1311+; 2- Headache (Migraine & TTH)114+; 7- Osteoarthritis (Knee)108+; 2- Neck & Shoulder Pain108+; 2- Primary outcome assessed as: Positive: + or Negative: -

2626 Conditions EffectivenessEfficacy +-+- Chronic Low Back Pain (n=13; # Combo n=2)10* # 230 Headache Conditions (n=11; # Combo n=1)4116#6# Osteoarthritic Conditions (n=10; # Combo n=2)713 # 1#1# Neck & Shoulder Conditions (n=10; # Combo n=1)425#5# 0 *No Treatment Control, # Both CER & Efficacy Designs Differing Lenses

2727 Conditions EffectivenessEfficacy +-+- Chronic Low Back Pain (n=13; # Combo n=2)10* # 230 Headache Conditions (n=11; # Combo n=1)4116#6# Osteoarthritic Conditions (n=10; # Combo n=2)713 # 1#1# Neck & Shoulder Conditions (n=10; # Combo n=1)425#5# 0 Differing Lenses *No Treatment Control, # Both CER & Efficacy Designs

2828 Conditions EffectivenessEfficacy +-+- Chronic Low Back Pain (n=13; # Combo n=2)10* # 230 Headache Conditions (n=11; # Combo n=1)4116#6# Osteoarthritic Conditions (n=10; # Combo n=2)713 # 1#1# Neck & Shoulder Conditions (n=10; # Combo n=1)425#5# 0 Differing Lenses *No Treatment Control, # Both CER & Efficacy Designs

2929 Conditions EffectivenessEfficacy +-+- Chronic Low Back Pain (n=13; # Combo n=2)10* # 230 Headache Conditions (n=11; # Combo n=1)4116#6# Osteoarthritic Conditions (n=10; # Combo n=2)713 # 1#1# Neck & Shoulder Conditions (n=10; # Combo n=1)425#5# 0 Differing Lenses *No Treatment Control, # Both CER & Efficacy Designs

3030 Pregnancy & Labor (n=18) Effectiven essEfficacy +-+- Pain During Labor (n=4)2020 Emesis in Pregnancy (n=3)1002 Initiation of Labor (n=3)2100 Pain During IVF Procedures (n=3)2010 Pregnancy Rate with IVF Procedures (n=3)1011 Breech Presentation (n=1)1*000 Pelvic Pain During Pregnancy (n=1)1000 TOTAL10143 *No Treatment Control Differing Lenses

31 Conclusions  A significant focus of research (45%) has been on previously understudied conditions  The lens of comparative effectiveness research, lends clarity Acupuncture has demonstrated consistent benefit for the treatment of each of the five most often investigated areas Acupuncture has demonstrated consistent benefit for the treatment of each of the five most often investigated areas 31

32 Conclusions  We suggest new recommendations regarding the benefits of acupuncture  “Showing efficacy” list Chronic low back pain (11+/2-) Chronic low back pain (11+/2-) Headache conditions (4+/7-, CER Lens 4+/1-) Headache conditions (4+/7-, CER Lens 4+/1-) Osteoarthritic conditions (8+/2-) Osteoarthritic conditions (8+/2-) Neck & shoulder pain conditions (8+/2-) Neck & shoulder pain conditions (8+/2-) Pregnancy & labor related conditions Pregnancy & labor related conditions Pain during labor (4+/0-)Pain during labor (4+/0-) 32

33 Conclusions  We suggest new recommendations regarding the benefits of acupuncture  “May be Useful” list Peri-op/Post-op Pain (7+/1-) Peri-op/Post-op Pain (7+/1-) Anxiety (3+/1-) Anxiety (3+/1-) Pregnancy & labor related conditions Pregnancy & labor related conditions Pain during IVF proceduresPain during IVF procedures Rhinitis (3+/0-) Rhinitis (3+/0-) 33

34 Future Directions  Update currently underway of RCTs published from ~150 RCTs ~150 RCTs  Consider ways to assess clinical relevance e.g. ecological validity 34

35 Many Thanks to the OCSI Team: Richard Hammerschlag, PhD Mikel Aikin, PhD Agatha Colbert, MD, LAc Scott Mist, PhD, LAc Jeffrey Weih, LAc Beth Yohalem-Ilsley, LAc Questions? Many Thanks to the OCSI Team: Richard Hammerschlag, PhD Mikel Aikin, PhD Agatha Colbert, MD, LAc Scott Mist, PhD, LAc Jeffrey Weih, LAc Beth Yohalem-Ilsley, LAc Questions? 35 Many Thanks to the OCSI TEAM Richard Hammerschag, PhD Mikel Aikin, PhD Agatha Colbert, MD Scott Mist, PhD, Lac Jeffrey Weih, Lac Beth Yohalem-Ilsley, Lac Questions?